A phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical stage II/III squamous cell carcinoma of the anal canal (JCOG0903, SMART-AC)
- Conditions
- anal canal caner
- Registration Number
- JPRN-UMIN000003237
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 71
Not provided
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Patients requiring the administration of phenytoin or warfarin potassium 3) Pregnant or lactating women or women of childbearing potential 4) Psychosis 5) Patients requiring systemic steroids medication 6) Serum HBs antigen positive 7) Anti-HIV antibody positive 8) Uncontrollable diabetes mellitus or administration of insulin. 9) Uncontrollable hypertention 10) Unstable angina, heart failure, or with a history of myocardial infarction within 6 months. 11) Interstitial pneumonia, fibroid lung, or severe emphysema 12) Active bacterial or fungous infection 13) fever over 38 degrees centigrade
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Incidence of dose limiting toxicity Phase II: Proportion of 3 year event-free survival
- Secondary Outcome Measures
Name Time Method Phase I: Incidence of adverse events Phase II: Complete response rate, progression-free survival, event-free survival, over all survival, colostomy-free survival, incidence of adverse events, and febril neutropenia